Clinical and Histological Outcomes of Allogenic Amnion Chorion Membrane in the Healing of Free Gingival Graft Donor Site
2021年12月17日 更新者：Chun-Teh Lee、The University of Texas Health Science Center, Houston
The purpose of this study is to compare an allogenic amnion chorion membrane to a collagen dressing in palatal wound healing after harvesting free gingival graft (FGG).
研究概览
研究类型
介入性
注册 (实际的)
19
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
Texas
-
Houston、Texas、美国、77030
- The University of Texas Health Science Center at Houston
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- patients attending the Clinic for Graduate Periodontics at The University of Texas health Science Center at Houston School of Dentistry who are in need of a Free Gingival Graft procedure to augment keratinized gingiva, augment ridge, or cover recession defects.
- systemically healthy or with controlled common systemic conditions, such as hypertension, that will not affect wound healing.
Exclusion Criteria:
- size of the FGG that the patient needs bigger than the size of FGGs that have to be harvested in this study (two 8mm (width) x 10mm (length) x ≈1.5mm (thickness) FGG).
- current heavy smokers(>10 cigarettes/day) (patients who stop smoking more than one year are eligible)
- have diabetes or other systemic diseases that may comprise healing
- take antibiotics and/or analgesics within one week before the procedure and have loss of sensation on the palate
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Allogenic amnion chorion membrane
Allogenic amnion chorion membrane (ACM) is a minimally manipulated allograft amnion chorion tissue for use as a wound covering in dental surgery.
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Allogenic amnion chorion membrane (ACM) is a minimally manipulated allograft amnion chorion tissue for use as a wound covering in dental surgery.
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有源比较器：Collagen dressing
Collagen dressing is used to cover wounds in dental surgery.
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Collagen dressing is used to cover wounds in dental surgery.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Size of Wound Area
大体时间：baseline
|
The wound area will be assessed by means of a clinical picture.
The picture will be taken with an angulation perpendicular to the wound.
A periodontal probe will be placed by the wound as a reference scale.
Wound area is defined as the area without epithelization.
The wound area on the picture will be measured by ImageJ.
|
baseline
|
|
Size of Wound Area
大体时间：4 days
|
The wound area will be assessed by means of a clinical picture.
The picture will be taken with an angulation perpendicular to the wound.
A periodontal probe will be placed by the wound as a reference scale.
Wound area is defined as the area without epithelization.
The wound area on the picture will be measured by ImageJ.
|
4 days
|
|
Size of Wound Area
大体时间：10 days
|
The wound area will be assessed by means of a clinical picture.
The picture will be taken with an angulation perpendicular to the wound.
A periodontal probe will be placed by the wound as a reference scale.
Wound area is defined as the area without epithelization.
The wound area on the picture will be measured by ImageJ.
|
10 days
|
|
Size of Wound Area
大体时间：14 days
|
The wound area will be assessed by means of a clinical picture.
The picture will be taken with an angulation perpendicular to the wound.
A periodontal probe will be placed by the wound as a reference scale.
Wound area is defined as the area without epithelization.
The wound area on the picture will be measured by ImageJ.
|
14 days
|
|
Size of Wound Area
大体时间：21 days
|
The wound area will be assessed by means of a clinical picture.
The picture will be taken with an angulation perpendicular to the wound.
A periodontal probe will be placed by the wound as a reference scale.
Wound area is defined as the area without epithelization.
The wound area on the picture will be measured by ImageJ.
|
21 days
|
|
Size of Wound Area
大体时间：28 days
|
The wound area will be assessed by means of a clinical picture.
The picture will be taken with an angulation perpendicular to the wound.
A periodontal probe will be placed by the wound as a reference scale.
Wound area is defined as the area without epithelization.
The wound area on the picture will be measured by ImageJ.
|
28 days
|
|
Size of Wound Area
大体时间：45 days
|
The wound area will be assessed by means of a clinical picture.
The picture will be taken with an angulation perpendicular to the wound.
A periodontal probe will be placed by the wound as a reference scale.
Wound area is defined as the area without epithelization.
The wound area on the picture will be measured by ImageJ.
|
45 days
|
|
Size of Wound Area
大体时间：60 days
|
The wound area will be assessed by means of a clinical picture.
The picture will be taken with an angulation perpendicular to the wound.
A periodontal probe will be placed by the wound as a reference scale.
Wound area is defined as the area without epithelization.
The wound area on the picture will be measured by ImageJ.
|
60 days
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Number of Participants Stratified as Per the Degree of Epithelialization of Wound
大体时间：baseline
|
Epithelialization is measured by means of bubble formation after dripping hydrogen peroxide (3%) to the wound surface.
Less bubbles indicate greater epithelialization, and epithelialization will be ranked as total, partial or none.
|
baseline
|
|
Number of Participants Stratified as Per the Degree of Epithelialization of Wound
大体时间：4 days
|
Epithelialization is measured by means of bubble formation after dripping hydrogen peroxide (3%) to the wound surface.
Less bubbles indicate greater epithelialization, and epithelialization will be ranked as total, partial or none.
|
4 days
|
|
Number of Participants Stratified as Per the Degree of Epithelialization of Wound
大体时间：10 days
|
Epithelialization is measured by means of bubble formation after dripping hydrogen peroxide (3%) to the wound surface.
Less bubbles indicate greater epithelialization, and epithelialization will be ranked as total, partial or none.
|
10 days
|
|
Number of Participants Stratified as Per the Degree of Epithelialization of Wound
大体时间：14 days
|
Epithelialization is measured by means of bubble formation after dripping hydrogen peroxide (3%) to the wound surface.
Less bubbles indicate greater epithelialization, and epithelialization will be ranked as total, partial or none.
|
14 days
|
|
Number of Participants Stratified as Per the Degree of Epithelialization of Wound
大体时间：21 days
|
Epithelialization is measured by means of bubble formation after dripping hydrogen peroxide (3%) to the wound surface.
Less bubbles indicate greater epithelialization, and epithelialization will be ranked as total, partial or none.
|
21 days
|
|
Number of Participants Stratified as Per the Degree of Epithelialization of Wound
大体时间：28 days
|
Epithelialization is measured by means of bubble formation after dripping hydrogen peroxide (3%) to the wound surface.
Less bubbles indicate greater epithelialization, and epithelialization will be ranked as total, partial or none.
|
28 days
|
|
Number of Participants Stratified as Per the Degree of Epithelialization of Wound
大体时间：45 days
|
Epithelialization is measured by means of bubble formation after dripping hydrogen peroxide (3%) to the wound surface.
Less bubbles indicate greater epithelialization, and epithelialization will be ranked as total, partial or none.
|
45 days
|
|
Number of Participants Stratified as Per the Degree of Epithelialization of Wound
大体时间：60 days
|
Epithelialization is measured by means of bubble formation after dripping hydrogen peroxide (3%) to the wound surface.
Less bubbles indicate greater epithelialization, and epithelialization will be ranked as total, partial or none.
|
60 days
|
|
Relative Difference in Color of Wound Site Compared to Adjacent Gingiva
大体时间：baseline
|
The color of wound site will be compared to the adjacent gingiva by using a 4-point scale: 1. Obvious difference; 2. Noticeable difference; 3. Disguisable difference; or 4. No noticeable difference in comparison with adjacent gingiva.
|
baseline
|
|
Relative Difference in Color of Wound Site Compared to Adjacent Gingiva
大体时间：4 days
|
The color of wound site will be compared to the adjacent gingiva by using a 4-point scale: 1. Obvious difference; 2. Noticeable difference; 3. Disguisable difference; or 4. No noticeable difference in comparison with adjacent gingiva.
|
4 days
|
|
Relative Difference in Color of Wound Site Compared to Adjacent Gingiva
大体时间：10 days
|
The color of wound site will be compared to the adjacent gingiva by using a 4-point scale: 1. Obvious difference; 2. Noticeable difference; 3. Disguisable difference; or 4. No noticeable difference in comparison with adjacent gingiva.
|
10 days
|
|
Relative Difference in Color of Wound Site Compared to Adjacent Gingiva
大体时间：14 days
|
The color of wound site will be compared to the adjacent gingiva by using a 4-point scale: 1. Obvious difference; 2. Noticeable difference; 3. Disguisable difference; or 4. No noticeable difference in comparison with adjacent gingiva.
|
14 days
|
|
Relative Difference in Color of Wound Site Compared to Adjacent Gingiva
大体时间：21 days
|
The color of wound site will be compared to the adjacent gingiva by using a 4-point scale: 1. Obvious difference; 2. Noticeable difference; 3. Disguisable difference; or 4. No noticeable difference in comparison with adjacent gingiva.
|
21 days
|
|
Relative Difference in Color of Wound Site Compared to Adjacent Gingiva
大体时间：28 days
|
The color of wound site will be compared to the adjacent gingiva by using a 4-point scale: 1. Obvious difference; 2. Noticeable difference; 3. Disguisable difference; or 4. No noticeable difference in comparison with adjacent gingiva.
|
28 days
|
|
Relative Difference in Color of Wound Site Compared to Adjacent Gingiva
大体时间：45 days
|
The color of wound site will be compared to the adjacent gingiva by using a 4-point scale: 1. Obvious difference; 2. Noticeable difference; 3. Disguisable difference; or 4. No noticeable difference in comparison with adjacent gingiva.
|
45 days
|
|
Relative Difference in Color of Wound Site Compared to Adjacent Gingiva
大体时间：60 days
|
The color of wound site will be compared to the adjacent gingiva by using a 4-point scale: 1. Obvious difference; 2. Noticeable difference; 3. Disguisable difference; or 4. No noticeable difference in comparison with adjacent gingiva.
|
60 days
|
|
Number of Participants With Haemostasis of Wound Area
大体时间：baseline
|
Haemostasis is achieved when no bleeding of the wound site is actively seen.
|
baseline
|
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Number of Participants With Haemostasis of Wound Area
大体时间：4 days
|
Haemostasis is achieved when no bleeding of the wound site is actively seen.
|
4 days
|
|
Number of Participants With Haemostasis of Wound Area
大体时间：10 days
|
Haemostasis is achieved when no bleeding of the wound site is actively seen.
|
10 days
|
|
Number of Participants With Haemostasis of Wound Area
大体时间：14 days
|
Haemostasis is achieved when no bleeding of the wound site is actively seen.
|
14 days
|
|
Number of Participants With Haemostasis of Wound Area
大体时间：21 days
|
Haemostasis is achieved when no bleeding of the wound site is actively seen.
|
21 days
|
|
Number of Participants With Haemostasis of Wound Area
大体时间：28 days
|
Haemostasis is achieved when no bleeding of the wound site is actively seen.
|
28 days
|
|
Number of Participants With Haemostasis of Wound Area
大体时间：45 days
|
Haemostasis is achieved when no bleeding of the wound site is actively seen.
|
45 days
|
|
Number of Participants With Haemostasis of Wound Area
大体时间：60 days
|
Haemostasis is achieved when no bleeding of the wound site is actively seen.
|
60 days
|
|
Pain as Assessed by a Visual Analogue Scale (VAS)
大体时间：baseline
|
Pain will be assessed by a Visual Analogue Scale (VAS).
Scores range form 0 to 10. 0 indicates no pain, 1 indicates minimal pain, and 10 indicates severe pain.
|
baseline
|
|
Pain as Assessed by a Visual Analogue Scale (VAS)
大体时间：4 days
|
Pain will be assessed by a Visual Analogue Scale (VAS).
Scores range form 0 to 10. 0 indicates no pain, 1 indicates minimal pain, and 10 indicates severe pain.
|
4 days
|
|
Pain as Assessed by a Visual Analogue Scale (VAS)
大体时间：10 days
|
Pain will be assessed by a Visual Analogue Scale (VAS).
Scores range form 0 to 10. 0 indicates no pain, 1 indicates minimal pain, and 10 indicates severe pain.
|
10 days
|
|
Pain as Assessed by a Visual Analogue Scale (VAS)
大体时间：14 days
|
Pain will be assessed by a Visual Analogue Scale (VAS).
Scores range form 0 to 10. 0 indicates no pain, 1 indicates minimal pain, and 10 indicates severe pain.
|
14 days
|
|
Pain as Assessed by a Visual Analogue Scale (VAS)
大体时间：21 days
|
Pain will be assessed by a Visual Analogue Scale (VAS).
Scores range form 0 to 10. 0 indicates no pain, 1 indicates minimal pain, and 10 indicates severe pain.
|
21 days
|
|
Pain as Assessed by a Visual Analogue Scale (VAS)
大体时间：28 days
|
Pain will be assessed by a Visual Analogue Scale (VAS).
Scores range form 0 to 10. 0 indicates no pain, 1 indicates minimal pain, and 10 indicates severe pain.
|
28 days
|
|
Pain as Assessed by a Visual Analogue Scale (VAS)
大体时间：45 days
|
Pain will be assessed by a Visual Analogue Scale (VAS).
Scores range form 0 to 10. 0 indicates no pain, 1 indicates minimal pain, and 10 indicates severe pain.
|
45 days
|
|
Pain as Assessed by a Visual Analogue Scale (VAS)
大体时间：60 days
|
Pain will be assessed by a Visual Analogue Scale (VAS).
Scores range form 0 to 10. 0 indicates no pain, 1 indicates minimal pain, and 10 indicates severe pain.
|
60 days
|
|
Sensibility of the Wound Area as Indicated by Number of Participants Who Lost Sensation as Assessed by a 3-point Verbal Descriptor Scale (VDS)
大体时间：baseline
|
Sensibility will be assessed with a periodontal probe using a rubbing movement and pin-pressure nociception.
Patients will be asked to rate their sensitivity based on a 3-point verbal descriptor scale (VDS): no loss of sensation, mild/moderate loss of sensation, or severe loss of sensation.
|
baseline
|
|
Sensibility of the Wound Area as Indicated by Number of Participants Who Lost Sensation as Assessed by a 3-point Verbal Descriptor Scale (VDS)
大体时间：4 days
|
Sensibility will be assessed with a periodontal probe using a rubbing movement and pin-pressure nociception.
Patients will be asked to rate their sensibility based on a 3-point verbal descriptor scale (VDS): no loss of sensation, mild/moderate loss of sensation, or severe loss of sensation.
|
4 days
|
|
Sensibility of the Wound Area as Indicated by Number of Participants Who Lost Sensation as Assessed by a 3-point Verbal Descriptor Scale (VDS)
大体时间：10 days
|
Sensibility will be assessed with a periodontal probe using a rubbing movement and pin-pressure nociception.
Patients will be asked to rate their sensibility based on a 3-point verbal descriptor scale (VDS): no loss of sensation, mild/moderate loss of sensation, or severe loss of sensation.
|
10 days
|
|
Sensibility of the Wound Area as Indicated by Number of Participants Who Lost Sensation as Assessed by a 3-point Verbal Descriptor Scale (VDS)
大体时间：14 days
|
Sensibility will be assessed with a periodontal probe using a rubbing movement and pin-pressure nociception.
Patients will be asked to rate their sensibility based on a 3-point verbal descriptor scale (VDS): no loss of sensation, mild/moderate loss of sensation, or severe loss of sensation.
|
14 days
|
|
Sensibility of the Wound Area as Indicated by Number of Participants Who Lost Sensation as Assessed by a 3-point Verbal Descriptor Scale (VDS)
大体时间：21 days
|
Sensibility will be assessed with a periodontal probe using a rubbing movement and pin-pressure nociception.
Patients will be asked to rate their sensibility based on a 3-point verbal descriptor scale (VDS): no loss of sensation, mild/moderate loss of sensation, or severe loss of sensation.
|
21 days
|
|
Sensibility of the Wound Area as Indicated by Number of Participants Who Lost Sensation as Assessed by a 3-point Verbal Descriptor Scale (VDS)
大体时间：28 days
|
Sensibility will be assessed with a periodontal probe using a rubbing movement and pin-pressure nociception.
Patients will be asked to rate their sensibility based on a 3-point verbal descriptor scale (VDS): no loss of sensation, mild/moderate loss of sensation, or severe loss of sensation.
|
28 days
|
|
Sensibility of the Wound Area as Indicated by Number of Participants Who Lost Sensation as Assessed by a 3-point Verbal Descriptor Scale (VDS)
大体时间：45 days
|
Sensibility will be assessed with a periodontal probe using a rubbing movement and pin-pressure nociception.
Patients will be asked to rate their sensibility based on a 3-point verbal descriptor scale (VDS): no loss of sensation, mild/moderate loss of sensation, or severe loss of sensation.
|
45 days
|
|
Sensibility of the Wound Area as Indicated by Number of Participants Who Lost Sensation as Assessed by a 3-point Verbal Descriptor Scale (VDS)
大体时间：60 days
|
Sensibility will be assessed with a periodontal probe using a rubbing movement and pin-pressure nociception.
Patients will be asked to rate their sensibility based on a 3-point verbal descriptor scale (VDS): no loss of sensation, mild/moderate loss of sensation, or severe loss of sensation.
|
60 days
|
|
Volume of Wound
大体时间：baseline
|
The wound area will analyzed with an intraoral scanner, and three-dimensional images will be reconstructed to determine the volume of the wound.
|
baseline
|
|
Volume of Wound
大体时间：4 days
|
The wound area will analyzed with an intraoral scanner, and three-dimensional images will be reconstructed to determine the volume of the wound.
|
4 days
|
|
Volume of Wound
大体时间：10 days
|
The wound area will analyzed with an intraoral scanner, and three-dimensional images will be reconstructed to determine the volume of the wound.
|
10 days
|
|
Volume of Wound
大体时间：14 days
|
The wound area will analyzed with an intraoral scanner, and three-dimensional images will be reconstructed to determine the volume of the wound.
|
14 days
|
|
Volume of Wound
大体时间：21 days
|
The wound area will analyzed with an intraoral scanner, and three-dimensional images will be reconstructed to determine the volume of the wound.
|
21 days
|
|
Volume of Wound
大体时间：28 days
|
The wound area will analyzed with an intraoral scanner, and three-dimensional images will be reconstructed to determine the volume of the wound.
|
28 days
|
|
Volume of Wound
大体时间：45 days
|
The wound area will analyzed with an intraoral scanner, and three-dimensional images will be reconstructed to determine the volume of the wound.
|
45 days
|
|
Volume of Wound
大体时间：60 days
|
The wound area will analyzed with an intraoral scanner, and three-dimensional images will be reconstructed to determine the volume of the wound.
|
60 days
|
|
Clinician's Feedback on the Wound Dressing Material as Assessed by a Questionnaire
大体时间：at the time of placement of the wound dressing material
|
at the time of placement of the wound dressing material
|
|
|
Number of Neutrophil Cells as Assessed by Light Microscopy of Haematoxylin and Eosin (H&E)-Stained Biopsy Sections
大体时间：baseline
|
Gingival specimen biopsies (4mm in diameter, 1.5mm in thickness) will be harvested.
The histological sections will be evaluated using a Nikon light microscope.
|
baseline
|
|
Number of Neutrophil Cells as Assessed by Light Microscopy of Haematoxylin and Eosin (H&E)-Stained Biopsy Sections
大体时间：10 days
|
Gingival specimen biopsies (4mm in diameter, 1.5mm in thickness) will be harvested.
The histological sections will be evaluated using a Nikon light microscope.
|
10 days
|
|
Change in Percentage of Collagen Density in Wound Area as Assessed by Light Microscopy of Masson's Trichrome-stained Biopsy Sections
大体时间：baseline, 10 days
|
baseline, 10 days
|
|
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Thickness of the Epithelium as Assessed by Light Microscopy of Haematoxylin and Eosin (H&E)-Stained Biopsy Sections
大体时间：baseline
|
Gingival specimen biopsies (4mm in diameter, 1.5mm in thickness) will be harvested.
The histological sections will be evaluated using a Nikon light microscope, and Nikon NIS-Elements Advanced Research (AR) Imagine Software will be used to calculate the thickness of the epithelium.
|
baseline
|
|
Thickness of the Epithelium as Assessed by Light Microscopy of Haematoxylin and Eosin (H&E)-Stained Biopsy Sections
大体时间：10 days
|
Gingival specimen biopsies (4mm in diameter, 1.5mm in thickness) will be harvested.
The histological sections will be evaluated using a Nikon light microscope, and Nikon NIS-Elements Advanced Research (AR) Imagine Software will be used to calculate the thickness of the epithelium.
|
10 days
|
|
Angiogenesis as Indicated by Number of Blood Vessels as Assessed by Light Microscopy of Biopsy Sections Immunohistochemically Stained to Detect Factor VIII (Von Willebrandt Factor)
大体时间：baseline
|
baseline
|
|
|
Angiogenesis as Indicated by Number of Blood Vessels as Assessed by Light Microscopy of Biopsy Sections Immunohistochemically Stained to Detect Factor VIII (Von Willebrandt Factor)
大体时间：10 days
|
Gingival specimen biopsies (4mm in diameter, 1.5mm in thickness) will be harvested.
The histological sections will be evaluated using a Nikon light microscope, and the area of angiogenesis will be quantified using Nikon NIS Element AR Imagine Software.
|
10 days
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Chun-Teh Lee、The University of Texas Health Science Center, Houston
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2016年10月3日
初级完成 (实际的)
2020年1月17日
研究完成 (实际的)
2020年1月17日
研究注册日期
首次提交
2018年10月17日
首先提交符合 QC 标准的
2018年10月17日
首次发布 (实际的)
2018年10月19日
研究记录更新
最后更新发布 (实际的)
2022年1月19日
上次提交的符合 QC 标准的更新
2021年12月17日
最后验证
2021年12月1日
更多信息
与本研究相关的术语
其他研究编号
- HSC-DB-18-0303
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
是的
在美国制造并从美国出口的产品
不
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.